Environmental sampling and testing device

ABSTRACT

Provided is sampling and testing device for the detection of specific molds, allergens, viruses, bacteria, fungi, and other protein containing substances. Embodiments of the device include a sampling member slideably engaged with a base that contains a lateral flow strip adapted to detect specific analytes of interest. The sampling member defines a solvent reservoir that stores an elution solvent in a fluid-tight manner before the device is used to sample and test environmental surfaces. During slideable withdrawal of the sampling member from the base, the elution solvent stored in the reservoir is automatically released to a wick assembly of the sampling member. The wick assembly includes a wick adapted to receive, distribute, and retain the elution solvent. After a user samples an environmental surface for an analyte of interest with the elution solvent wetted wick, the sampling member is returned to the base where the wick contacts the lateral flow strip contained in the base. The wick transfers at least a portion of analyte and the elution solvent to the lateral flow strip for the calorimetric detection of specific allergens, viruses, bacteria, and other protein containing substances in the sample. The colorimetric results of the test are displayed through a window in the base.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to disposable colorimetricsampling devices, and, more specifically, to a user-friendly, simple touse, disposable colorimetric sampling device for the detection of one ormore specific potentially harmful substances in an environmental orbiological sample.

2. Description of the Related Art

Diagnostic assays for the determination of specific proteins inbiological and environmental samples are commonly used across variousindustries (environmental, biotech, healthcare, food, etc). With theincreased awareness of health and wellness in the home and other indoorenvironments and the outdoors, there is growing interest in assessingthe presence or absence of potentially harmful substances and howefficacious household cleaning products are in denaturing or destroyingmolds, allergens viruses, bacteria, and other proteins known to causenegative human and animal health effects.

Colorimetric assays utilizing sampling devices for the detection oftotal proteins in biological samples are commonly used across variousindustries (biotech, healthcare, food, etc). Protein detection assaysare available through biotechnology companies such as Pierce, Bio-Rad,and Biotrace International.

One such detection assay, described in U.S. Pat. No. 6,818,455 of May,et al., employs a porous carrier capillary device, sometimes referred toas a lateral flow strip, which provides mobilizable particulate labeledreagents for detection. Pregnancy test devices, well known to those ofordinary skill in the art, utilize lateral flow strips.

Prior art sampling and test devices utilizing lateral flow stripstypically comprised a hollow base constructed of moisture-impervioussolid material, such as plastic materials, containing a lateral flowstrip that communicated indirectly with the exterior of the base throughan absorbent wick which protruded from the base such that a liquid testsample could be applied to the wick and permeate therefrom to thelateral flow strip. The lateral flow strip typically included a mobilezone, containing a labeled analyte specific binding reagent, which wasfreely mobile within the mobile zone of the lateral flow strip when inthe moist state. The lateral flow strip of the prior art furtherincluded an indicia zone, spatially distinct from the mobile zone. Theindicia zone included an unlabelled specific binding reagent for thesame analyte. The unlabelled specific binding reagent that waspermanently immobilized on the lateral flow strip was not mobile in themoist state. The mobile zone and the indicia zone were arranged suchthat the liquid sample applied to the mobile zone of the lateral flowstrip permeated into the indicia zone by capillary action. The presenceof the analyte in the liquid sample was calorimetrically indicated inthe indicia zone of the lateral flow strip as the labeled reagentpermeated and become bound in the indicia zone. A user of the deviceobserved the colorimetric results through a window in the base.

While these sampling devices were used effectively by trained users, thecurrent devices and methods of detection were unsuitable for homediagnostic applications, because of their lack of user-friendlyqualities for those not skilled in science or trained in the use ofanalytical devices. Further, the possibility of misplacing the multipleparts of these devices and the lack of an efficient means ofdistributing the devices to consumers at a low cost complicated the widespread home use of the devices.

Further, these prior art sampling and testing devices were limited touse with liquid samples. The samples needed to be in a liquid formoriginally or the wick of the device needed to be separately wetted,through user manipulation, with a separately stored elution solvent,such as a liquid buffer, prior to sampling of dry surfaces of a samplingobject of interest.

Accordingly, there is a need for improved methods and sampling devicesfor convenient use in a household for the rapid detection of proteins inspecific molds, allergens, fungi, bacteria, or other protein-containingsubstances. More specifically, there is a need for the development of asampling and testing device and method that are equally or superiorlyreliable to the other options already available, but that are moreconveniently distributable to a large number of untrained users, moreconveniently usable in the home, and more easily disposed.

SUMMARY OF THE INVENTION

Disposable, simple to use sampling devices for the rapid detection ofgeneral and specific proteins, such as those of allergens, fungi,bacteria, and molds, have been developed. Embodiments of these devicesallow for simple, versatile sample collection from environmentalsurfaces and, the sensitive and semi-quantifiable analysis of the samplefor specific proteins. The device includes a base that defines a stripcavity, a wick cavity in fluid communication with the strip cavity, anda window.

Disposed within the strip cavity of the base, is a lateral flow striphaving a mobile zone and an indicia zone. The window in the baseoverlies the indicia zone making it visible to a user of the device. Thewindow may be covered by a transparent or translucent sheet to protectthe lateral flow strip from contamination. In one embodiment, thelateral flow strip may include an absorption zone opposite the mobilezone of the lateral flow strip. The absorption zone is beyond ordownstream of the indicia zone of the lateral flow strip. Thus, in thisembodiment, the indicia zone is interposed between the mobile zone andthe absorption zone. The absorption zone has sufficient size andporosity to receive and retain excess reagent/solvent transported beyondthe indicia zone during the use of the device of the present invention.

The device further includes a sampling member slideably engageable withthe wick cavity of the base. In one embodiment, the sampling memberdefines a solvent reservoir containing the elution solvent in afluid-tight manner when the sampling member is fully engaged with thewick cavity of the base. The sampling member includes a handle at oneend of the sampling member and a wick assembly at an opposite end of thesampling member. The wick assembly of the sampling member includes awick holder having a member coupling end and a wick coupling endopposite the member coupling end. The member coupling end of the wickholder is slideably coupled to the sampling end of the sampling member.An absorbent wick is fixedly coupled to the wick coupling end of thewick holder.

When a user of the device of the present invention, slideably disengagesand removes the sampling member from the wick cavity of the base, theelution solvent is automatically released from the solvent reservoir andflows to and is absorbed by the wick. When collecting a sample from anenvironmental surface of a sampling object of interest, the user of thedevice need not manually wet the wick with elution solvent in a separateoperation. The sampling member is then used to obtain an environmentalsample from a surface of a sampling object, the sample being collectedwith the elution solvent-wetted wick. When the sampling member isreinserted into the wick cavity of the base, the wick is therebypositively and securely placed in fluid communication with the lateralflow strip. A portion of the analyte collected from the environmentalsample and now contained in the elution solvent, is transported to theindicia zone of the strip where a colorimetric analysis for the analyteis completed and the results displayed. The time required to effect thecolor change in the indicia zone may be used to semi-quantify theconcentration of the analyte in the environmental sample when comparedto the time required to effect the color change for a sample of knowconcentrations.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will now be made to the drawings wherein like numerals referto like parts throughout, and wherein:

FIG. 1A is an isometric view of an embodiment of a sampling and testingdevice in accordance with the principles of the present invention thatincludes a base and a sampling member slideably engaged with base 102;

FIG. 1B is an exploded view showing further details of the samplingdevice of FIG. 1A;

FIG. 1C is an isometric view of the device similar to FIG. 1A showingthe sampling member disengaged and withdrawn from the base;

FIG. 2A is a top close-up view of a wick assembly of FIG. 1B thatincludes a wick holder and a wick fixedly coupled to the wick holder;

FIG. 2B is a bottom close-up view of the wick assembly of FIG. 1B;

FIG. 3A is a partial cross-section side view of the device taken alongthe line 3A′-3A′ of FIG. 1A;

FIG. 3B is a partial cross-section side view of the device of FIG. 1A,similar to FIG. 3A but with the sampling member partially withdrawn fromthe base; and

FIG. 3C is a partial cross-section side view of the device of FIG. 1A,taken along line 3C′-3C′ with the sampling member reinserted into thebase 102 after a sample has been collected from environmental surface Sof a sampling object.

DETAILED DESCRIPTION

The embodiments disclosed herein are described in the context of asampling and testing device for the rapid detection of specific molds,allergens, fungi, viruses, bacteria and other protein containingsubstances. One of ordinary skill in the art would recognize, however,that the materials and methods disclosed herein will have application ina number of other contexts where sampling and detection of the presenceor absence of a particular compound is desirable, particularly wheresimplicity and ease of use of a sampling/detection device is important.Further, the present invention will have application in contexts whereit is desirable to contain and store a fluid compound in a fluid-tightmanner until a user wishes to automatically dispense the fluid tosaturate an absorbent applicator wick.

FIG. 1A is an isometric view of an embodiment of a sampling and testingdevice 100, hereinafter device 100, in accordance with the principles ofthe present invention that includes a base 102 and a sampling member 104slideably engaged with base 102. FIG. 1B is an exploded view showingfurther details of the sampling device 100 of FIG. 1A. FIG. 1C is anisometric view showing sampling member 104 of device 100 slideablydisengaged and withdrawn from base 102. Referring to FIGS. 1A, 1B, and1C together, in one embodiment, base 102 includes a base top 102A havingan aperture or window 110 therethrough, and a base bottom 102B. As usedherein, positional terms, such as “top” and “bottom” and the like, anddirectional terms, such as “up” and “down” and the like, are employedfor ease of description in conjunction with the drawings. These termsare not meant to indicate that the components of the present inventionmust have a specific orientation except when specifically set forthbelow.

Base top 102A defines a wick cavity 112 adapted to receive and slideablyengage sampling member 104 of device 100. Wick cavity 112 protectssampling member 104 from external contamination prior to use of device100. Base top 102A is further adapted to couple with base bottom 102B todefine a strip cavity 106 therebetween (shown in exploded view in FIG.1B). When so formed, strip cavity 106 is in fluid communication withwick cavity 112.

A lateral flow strip 108 (FIG. 1B) is disposed within strip cavity 106formed when base top 102A is coupled with base bottom 102B. In oneembodiment, lateral flow strip 108 is configured as a substantially flatrectangular sheet of capillary material 108C, for example,nitrocellulose. At a lengthwise end of lateral flow strip 108 nearestwick cavity 112, lateral flow strip 108 includes a mobile zone 108A.Mobile zone 108A contains at least one labeled reagent capable ofspecific binding with an analyte of interest, such as a specific mold,fungi, or bacteria, to form a complex of the labeled reagent and thespecific analyte. When in the liquid state, the labeled specific bindingreagent is freely mobile within the mobile zone 108A of lateral flowstrip 108. In one embodiment, the labeled reagent capable of specificbinding with an analyte of interest is an antigen.

Lateral flow strip 108 further includes at least one indicia zone 108Bcontaining a permanently immobilized and unlabelled specific bindingreagent for the same analyte of interest. Indicia zone 108B ispositioned at a lengthwise end of lateral flow strip 108 opposite mobilezone 108A such that a liquid sample applied to mobile zone 108A can pickup labeled specific binding reagent and thereafter permeate into indiciazone 108B through capillary material 108C. In one embodiment, theimmobilized and unlabelled specific binding reagent is an antibody.

When base 102 is assembled as described, indicia zone 108B is visiblethrough window 110 of base top 102A. The presence of the specificanalyte of interest in a liquid sample is calorimetrically indicated inindicia zone 108B as the labeled reagent permeates and becomes bound inindicia zone 108B. The colorimetric results are observable by a user ofdevice 100 through window 110. Window 110 may be covered by atransparent or translucent sheet of material (not shown) to protect andisolate indicia zone 108B from contamination from the environmentexternal to device 100. In one embodiment, lateral flow strip furtherincludes an absorption zone (not shown) adjacent to and downstream ofindicia zone 108B. The absorption zone is adapted to receive and retainexcess labeled reagent and an elution solvent 334 (FIG. 3A) that maypermeate through indicia zone 108B.

As best seen in FIG. 1B, sampling member 104 includes a handle 114having a wick coupling end 114A and a gripping end 114B opposite wickcoupling end 114A. Handle 114 defines a solvent reservoir 118 adapted tocontain an elution solvent 334 (FIG. 3A). In one embodiment, elutionsolvent 334 is a liquid buffer comprising phosphate buffers or alcoholbased buffers. Solvent reservoir 118 is configured as a hollow,open-ended cylinder having a reservoir opening 118A on one end. Handle114 further defines a withdrawal indent 125. As described andillustrated more fully below with reference to FIGS. 3A and 3B,withdrawal indent 125 is adapted to cooperate with a withdrawal snapdetent 232 (FIGS. 2B, 3A and 3B) during the slideable withdrawal ofsampling member 104 from base 102 by a user of device 100.

Sampling member 104 further includes a wick assembly 116 coupled tohandle 114. Wick assembly 116 of sampling member 104 includes a wickholder 120 having a handle coupling end 120A and a wick coupling end120B opposite handle coupling end 120A. Handle coupling end 120A of wickholder 120 is adapted to initially slideably couple with wick couplingend 114A of handle 114. Thus, as described and illustrated more fullybelow with reference to FIG. 3A, handle 114 may slideably move outwardlyaway from wick holder 120 when a user of device 100 initiates withdrawalof sampling member 104 from base 102.

A wick 124 is fixedly coupled to and secured to wick holder 120 at wickcoupling end 120B of wick holder 120. In one embodiment, wick 124 isformed from an absorbent material, such as by way of example and notlimitation, synthetic polyurethane, polyester, and polyproplene. Wick124 is adapted to receive, distribute, and retain a fluid. A seal crushrib (not shown), well known to those of ordinary skill in the art, maybe placed around the perimeter of wick holder 120 adjacent handlecoupling end 120A of wick holder 120 to prevent fluid from bypassingwick 124. As described and illustrated more fully below with referenceto FIGS. 3A and 3B, a sealing ring 122 assists in formation of areleasable fluid-tight seal between solvent reservoir 118 and wickholder 120.

FIG. 2A is a top close-up view of wick assembly 116 of FIG. 1B with wick124 fixedly coupled to wick coupling end 120B of wick holder 120. Asshown, wick holder 120 includes one or more slots 226. Slots 226 areconfigured as openings through wick holder 120 about at least a portionof wick holder 120 at its handle coupling end 120A. Slots 226 providepassageways that place the exterior of wick holder 120 in fluidcommunication with wick 124. Fluid may pass through slots 226 from theexterior of wick holder 120 to saturate wick 124. As would be apparentto one of ordinary skill in the art, other configurations and positionsfor slots 226 to provide fluid communication to wick 124 are possible.

As also shown in FIG. 2A, wick holder 120 further includes a catchindent 228. As described and illustrated more fully below with referenceto FIGS. 3A and 3B, catch indent 228 is adapted to cooperate with acatch detent 336 (FIGS. 3A and 3B) in locking engagement during theslideable withdrawal of sampling member 104 from base 102 (FIG. 1C) by auser of device 100. Finally as shown, wick holder 120 includes areservoir plug 230. As also described and illustrated more fully belowwith reference to FIGS. 3A and 3B, reservoir plug 230 is adapted tocooperate with reservoir 118, and more specifically with reservoiropening 118A, (FIG. 1B) in sealing engagement to form a fluid-tight sealtherebetween. In the embodiment shown, reservoir plug 230 is configuredas a cylindrical stopper or bung fixedly coupled to or integral withwick holder 120 at its handle coupling end 120A. In one embodiment,sealing ring 122, configured as an “O” ring, well known to those ofordinary skill in the art, circumscribes reservoir plug 230 to aid inthe formation of the fluid-tight seal between reservoir plug 230 andreservoir opening 118A.

FIG. 2B is a bottom close-up view of wick assembly 116 of FIG. 1B withwick 124 fixedly coupled to and partially retained within wick holder120. Wick holder 120 includes a withdrawal snap detent 232 coupled to aflex member 234 at one end thereof. Flex member 234 is coupled to thetop of wick holder 120 only at the end of flex member 234 oppositewithdrawal snap detent 232, thereby forming a living hinge 233 at thepoint of coupling. Withdrawal snap detent 232 may pivot about livinghinge 233 inwardly toward the inside of wick holder 120. Wick 124,partially contained within wick holder 120, may be formed from crushableor flexible material to avoid interference with and to accommodate theinward movement of withdrawal snap detent 232. When so pivoted inwardly,flex member 234 produces an elastic biasing force tending to returnwithdrawal snap detent 232 to its relaxed position before pivoting. Asdescribed and illustrated more fully directly below with reference toFIGS. 3A and 3B, withdrawal snap detent 232 is adapted to cooperate withwithdrawal indent 125 (FIG. 1B) in temporary locking engagement duringthe initial slideable withdrawal of sampling member 104 from base 102 bya user of device 100.

FIG. 3A is a partial cross-section side view of device 100 taken alongthe line 3A′-3A′ of FIG. 1A. As in FIG. 1A, sampling member 104 is fullyengaged with base 102 of device 100. In this configuration, wickassembly 116 (FIG. 1A) is enclosed within wick cavity 112 of base 102.When engaged as shown, solvent reservoir 118 retains an elution solvent334, which, in one embodiment, is a flow able fluid. The cylindricallyshaped outer peripheral sidewall of reservoir plug 230 abuts andsealingly engages the cylindrically shaped inner sidewall of solventreservoir 118 to seal off the opened end of solvent reservoir 118 tocontain elution solvent 334 within reservoir 118.

Further, in this fully engaged configuration, catch indent 228 of wickholder 120 is lockingly engaged with a catch detent 336 of base 102 byinterference therebetween. The protrusion of catch detent 336 is withinthe indentation of catch indent 228. In this configuration, catch indent228 and catch detent 336 cooperate to resist both inward and outwardsliding motion of wick holder 120, and consequently wick 124 coupledthereto, relative to base 102. Still further, in this fully engagedconfiguration, withdrawal snap detent 232 is flexed inwardly toward theinside of wick holder 120. As described above with reference to FIG. 2B,withdrawal snap detent 232 may pivot inwardly toward the inside of wickholder 120 about living hinge 233. When so pivoted inwardly as shown,flex member 234 produces an elastic biasing force tending to returnwithdrawal snap detent 232 outwardly toward its relaxed position beforepivoting. However, as shown in FIG. 3A, this biasing force is resistedby the top of handle 114. More particularly, the biasing force tendingto return snap detent 232 outwardly toward its relaxed position isresisted by the top of wick coupling end 114A that is beyond withdrawalindent 125 in a direction toward reservoir 118. Thus, in this fullyengaged configuration, snap detent 232 is contained within the inside ofwick holder 120, while, at the same time, an outwardly biasing force onsnap detent 232 is produced by flex member 234.

FIG. 3B is a partial cross-section side view of device 100 of FIG. 1A,similar to FIG. 3A but with sampling member 104 partially withdrawn frombase 102. As shown by dimension arrow 335, handle 114 has movedoutwardly relative to wick holder 120. This outward movement may beinitiated by a user of device 100. A user may grasp and pull outwardlyon gripping end 114B of handle 114 (FIG. 1B) with one hand while, at thesame time, holding base 102 stationary with the other hand. Since catchindent 228 of wick holder 120 is lockingly engaged with catch detent 336of base 102, as described above with reference to FIG. 3A, wick holder120 is initially constrained from moving outwardly as handle 114 ofsampling member 104 is withdrawn from base 102.

Recalling that handle coupling end 120A of wick holder 120 is adapted toslideably engage with wick coupling end 114A of handle 114, handle 114may slideably move outwardly away from wick holder 120. As samplingmember 104 is withdrawn from a stationary base 102, wick holder 120 isheld stationary to base 102 by the cooperation of catch indent 228 andcatch detent 125 as described, and handle coupling end 120A of wickholder 120 slides within wick coupling end 114A of handle 114.

In this manner, reservoir plug 230 is released from sealing engagementwith reservoir 118. At the point of partial withdrawal shown, because ofthe outward movement of handle 114 relative to wick holder 120,reservoir plug 230 of wick holder 120 clears reservoir opening 118A ofreservoir 118 and enters a wide portion of handle 114 at its wickcoupling end 114A. Reservoir opening 118A has a first diameter D1 andwick coupling end 114A of handle 114 has a second diameter. Firstdiameter D1 of reservoir opening 118A is smaller than second diameter D2of wick coupling end 114A of handle 114. Further, as shown, sealing ring122 circumscribing reservoir plug 230 has likewise cleared reservoiropening 118A of reservoir 118.

Thus at this point of partial slideable withdrawal of sampling member104 from base 102, elution solvent 334 flows from reservoir 118 intowick coupling end 114A of handle 114 through the gap created betweenreservoir plug 230 and reservoir opening 118A by the partial withdrawalof sampling member 104 from base 102. As regent 334 flows into wickcoupling end 114A of handle 114, strainer slots 226 (see also FIGS. 2Aand 2B), configured as openings through wick holder 120, providepassageways for elution solvent 334 to flow through and contact wick124. Since, as noted, wick 124 is formed from absorbent material,elution solvent 334 is received, distributed, and retained on wick 124.

Further, at the point of partial withdrawal of sampling member 104 frombase 102 shown in FIG. 3B, withdrawal snap detent 232 of handle 114lockingly engages withdrawal indent 125 of wick coupling end of wickholder 120. As described above with reference to FIG. 2B, wick holder120 includes withdrawal snap detent 232 coupled to flex member 234 atone end thereof. As described above with reference to FIG. 3A, anoutwardly directed biasing force on withdrawal snap detent 232 isproduced by flex member 234 when sampling member 104 is fully insertedwithin base 102.

When withdrawal snap detent 232 aligns with withdrawal indent 125, thebiasing force on withdrawal snap detent 232 operates to move withdrawalsnap detent 232 outwardly toward its relaxed position there to form alocking engagement with withdrawal indent 125. The initial outwardmovement of handle 114 relative to wick holder 120 provides foralignment of withdrawal snap detent 232 with withdrawal indent 125. Inone embodiment, withdrawal snap detent 232 produces a “snapping” soundas it lockingly engages withdrawal indent 125 during partial withdrawalof sampling member 104 from base 102 by a user of device 100.

As a user of device 100 attempts further withdrawal of sampling member104 from base 102 beyond that show in FIG. 3B a conflict occurs. Thelocking engagement of catch indent 228 with catch detent 336 restrainsthe outward movement of wick holder 120. At the same time, the lockingengagement of withdrawal snap detent 232 and withdrawal indent 125transfers the withdrawal force supplied by a user to handle 114 ofsampling member 104 to wick holder 120 of sampling member 104, therebymotivating wick hold 120 to move outwardly from base 102 along withhandle 114.

In accordance with the principle of the present invention, the lockingengagement of catch indent 228 with catch detent 336 is less forcefulthan the locking engagement of withdrawal snap detent 232 withwithdrawal indent 125. Thus, as a user continues to withdraw samplingmember 104 from base 102, the locking engagement of catch indent 228 ofwick holder 120 with catch detent 336 of base 102 preferentially yieldsover the locking engagement of withdrawal snap detent 232 and withdrawalindent 125. Thus wick hold 120, still lockingly engaged with and coupledto handle 114, is withdrawn along with handle 114.

The preferential yielding of the locking engagement of catch indent 228with catch detent 336 may be accomplished variously. In one embodiment,for example, the spatial interference between catch indent 228 of wickholder 120 and catch detent 336 is less than the spatial interferencebetween withdrawal snap detent 232 and withdrawal indent 125. In anotherembodiment, catch detent 336 shears from base 102 as withdrawal ofsampling member 104 from base 102 proceeds. In still another embodiment,catch indent 228 and/or catch detent 336 deform and yield duringcontinued withdrawal to release the locking engagement of catch indent228 with catch detent 336. Other embodiments that provide forpreferential yielding of the locking engagement of catch indent 228 ofwick holder 120 with catch detent 336 of base 102 would be apparent tothose of ordinary skill in the art.

Referring again to FIG. 1C, once sampling member 104, including handle114 and wick assembly 116 having wick 124 saturated with elution solvent334 (not shown in FIG. 1C), is fully withdrawn from base 102 (FIG. 1B),a user of device 100 contacts and wipes an environmental surface S of asampling object with wick 124 to collect a sample of materials containedon environmental surface S. Since wick 124 has been wetted with elutionsolvent 334 (FIG. 3B) at withdrawal of sampling member 104 from base 102as described above with reference to FIGS. 3A and 3B, there is no needfor the user of device 100 to manually wet wick 124 in a separateoperation. A user simply manipulates sampling member 104 with bygrasping handle 114 at its gripping end 114B to collect a sample withwick 124 wetted with elution solvent 334. Environmental surface S maycontain allergens, viruses, bacteria and other protein containinganalytes of interest, which are collected for analysis.

After a sample of material contained on environmental surface S iscollected, a user slideably reinserts sampling member 104 back into base102. FIG. 3C is a partial cross-section side view of device 100 of FIG.1A, taken along line 3C′-3C′ with sampling member 104 reinserted intobase 102 after a sample has been collected from environmental surface S(FIG. 1C) of a sampling object. As noted above with reference to FIG.3B, during withdrawal of sampling member 104 from base 102, handle 114(FIG. 3B) has moved outwardly relative to wick holder 120, when comparedto the position of handle 114 to wick holder 120 before withdrawal (FIG.3A). Thus, during withdrawal, the overall length of sampling member 104,from wick 124 to gripping end 114B of handle 114 (FIG. 3C), increases bythe amount shown by dimension arrow 335 (FIG. 3B). As lengthenedsampling member 104 is reinserted into base 102, wick 124, now fixedlycoupled to wick holder 120, encounters the end of wick cavity 112 (seealso FIG. 1B) and bends downwardly to securely and positively compressagainst lateral flow strip 108. In this manner, the sample of materialscontained on environmental surface S, which were collected within regent334 absorbed on wick 124 during sampling, are placed in fluidcommunication with and transferred to mobile zone 108A of lateral flowstrip 108. Lateral flow strip provides a calorimetric indication ofspecific allergens, molds, viruses, bacteria, fungi, and other proteincontaining substances of interest that the environmental surface S maycontain at indicia zone 108B of lateral flow strip 108 through window110 of base 102.

Thus, embodiments of the present invention provide a sampling and testdevice that includes a sampling member slideable coupled to base thatcontains a lateral flow strip adapted to detect specific molds,allergens, viruses, fungi, bacteria, and other protein containingsubstances. The sample member defines a solvent reservoir that stores areagent before the device is used to sample and test environmentalsurfaces. During withdrawal by a user of the sampling member from thebase, the elution solvent stored in the reservoir is automaticallyreleased to a wick assembly of the sampling member. The wick assemblyincludes a wick adapted to receive, distribute, and retain the elutionsolvent. The user of the device need not manually wet the wick withelution solvent in a separate operation. After a user samples anenvironmental surface with the elution solvent wetted wick of thewithdrawn sampling member, the sampling member is slideable reinsertedinto the base where the wick contacts the lateral flow strip containedin the base. The wick transfer at least a portion of sample and theelution solvent to the lateral flow strip for the colorimetric detectionof specific molds, allergens, viruses, bacteria, fungi, and otherprotein containing substances that may be contained in the sample. Thecolorimetric results of the test are displayed through a window in thebase.

The present invention has been described herein in considerable detailto provide those skilled in the art with information relevant to applythe novel principles and to construct and use such specializedcomponents as are required. Specifically, embodiments of the samplingdevice and method have been described with reference to the detection ofprotein-containing substance such as mold, bacteria, fungi, andallergens. More specifically, the present invention has been describedwith reference to a colorimeter test. However, those of ordinary skillin the art will readily appreciate that the present invention isadaptable to any number of colorimetric tests. Further, it is to beunderstood that the present invention can be carried out by differentequipment, materials and devices, and that various modifications, bothas to the equipment and operating procedures, can be accomplishedwithout departing from the scope of the invention itself.

For example, the solvent reservoir of the present invention may bedivided by a separating baffle into two or more compartments. In thisembodiment, when withdrawing the sampling member from the base only onefluid is released from its separate compartment to be absorbed on thewick of the sampling member, with the second fluid being retained withinits separate reservoir compartment by a septum or the like. Uponreinsertion of the sampling member into the base after a sample has beenobtained, the septum retaining the second fluid may be punctured with,for example, a manually operated prod, to release the second fluid.

This embodiment would find application where the environmental surfacecontains only a low concentration of the specific analyte below thelevel of detection of the lateral flow strip. In this example, the firstfluid, released and absorbed by the wick upon withdrawal of the samplingmember, could be a growth medium for the analyte of interest. Thereinsertion of the sampling member could be delayed for a period of timenecessary for the analyte to propagate in the growth medium to adetectable concentration. Upon delayed reinsertion of the samplingmember, the second fluid, such as an elution solvent for the completionof the lateral flow strip analysis, could then be manually released toinitiate testing.

In another example involving a dual chambered reservoir, specificantibiotics or biocides could be released to the wick from a firstreservoir chamber when the sampling member is withdrawn form the base.Thus, only analytes that is resistance to the specific antibiotic willbe tested. These examples could be combined by adding selective biocideor antibiotic agents in a growth medium applied to the wick uponwithdrawal of the sampling member from the base.

In another embodiment, a dispensing device according to the presentinvention could be used as a dispenser for fluid cosmetics, externallyapplied fluid medicines and the like. The fluid compound is stored andthen automatically released from a fluid compound reservoir in adispensing applicator to a wick upon withdrawal of the dispensingapplicator from a base. Other details of the dispenser are similar tothose described above for the sampling and testing device and so are notrepeated here. The wick could then by used as an applicator for theabsorbed cosmetic or medicine. In this embodiment, a lateral flow strip,strip cavity, and window would not be required since no analysis isperformed.

In yet another example, a general method for the rapid detection ofspecific molds, allergens, viruses, fungi, bacteria, and other proteincontaining substances includes: providing a sampling and testing devicefor collecting a sample and detecting one or more specific proteincontaining analytes of interest; removing a wick assembly having a wickfrom a base of the sampling and testing device; optionally, releasing tothe wick one or more fluids stored separately in one or more reservoirsof the sampling and testing device; collecting a sample on the wick ofthe wick assembly; reinserting the wick assembly into the base afterobtaining a sample; optionally releasing to the wick one or moreadditional fluids stored separately in the one or more reservoirs, and;observing calorimetric results displayed on an indicia zone of a lateralflow strip contained within the sampling and testing device.

The method can be adapted to detecting specific molds, allergens,viruses, fungi, bacteria, and other protein containing substances inenvironmental samples or in biological samples such as human spittle ornasal fluid. In one embodiment, the fluid is an elution solvent that isreleased when the wick assembly is first removed from the base. Inanother embodiment, the fluid is a growth medium for an analyte ofinterest. In yet another embodiment, no fluid is released to the wickupon withdrawal of the wick assembly from the base. In this embodiment,a fluid is released to the wick upon reinsertion of the wick assemblyinto the base after sampling.

1. A sampling and testing device for collecting an environmental sampleand detecting an analyte of interest suspected of being present in saidenvironmental sample, said sampling and testing device comprising: abase, said base defining a strip cavity, a wick cavity, and a window; alateral flow strip disposed within said strip cavity of said base, saidlateral flow strip having a mobile zone and an indicia zone adjacentsaid mobile zone; a sampling member having a handle and a wick assemblycoupled to said handle, wherein said sampling member defines a solventreservoir containing an elution solvent; wherein said wick assemblycomprises: a wick holder having slots therethrough; and a wick coupledto said wick holder; wherein said wick assembly is slideably engageablewith said wick cavity of said base; wherein said elution solvent isinitially contained within said solvent reservoir in a fluid-tightmanner when said sampling member is fully engaged with said base; andwherein said elution solvent is released from said solvent reservoirinto said wick through said slots of said wick holder when said samplingmember is withdrawn from said base.
 2. The sampling and testing deviceof claim 1 wherein said indicia zone is visible through said window. 3.The sampling and testing device of claim 1 wherein the presence of aspecific analyte of interest in a sample is indicated in said indiciazone by colorimetric display.
 4. The sampling and testing device ofclaim 1 wherein said elution solvent comprises a buffer solution.
 5. Thesampling and testing device of claim 4 wherein said buffer solution isselected from the group consisting of phosphate buffers and alcoholbased buffers.
 6. The sampling and testing device of claim 1 whereinsaid lateral flow strip further comprises an absorption zone downstreamof said indicia zone of said lateral flow strip.
 7. The sampling andtesting device of claim 6 wherein said absorption zone has sufficientsize and porosity to receive and retain said elution solvent thatpermeates beyond said indicia zone during use of said sampling andtesting device.
 8. The sampling and testing device of claim 1 whereinsaid lateral flow strip is configured as a substantially flatrectangular sheet of capillary material.
 9. The sampling and testingdevice of claim 8 wherein said capillary material comprisesnitrocellulose.
 10. The sampling and testing device of claim 1 whereinsaid mobile zone contains at least one labeled reagent capable ofspecific binding with an analyte of interest.
 11. The sampling andtesting device of claim 10 wherein said analyte of interest is selectedfrom the group consisting of allergens, viruses, bacteria, and otherprotein containing substances.
 12. The sampling and testing device ofclaim 11 wherein said indicia zone contains a permanently immobilizedand unlabelled specific binding reagent for said analyte of interest.13. The sampling and testing device of claim 1 wherein said solventreservoir is configured as a hollow cylinder having a reservoir openingon one end of said solvent reservoir.
 14. The sampling and testingdevice of claim 1 wherein said a wick holder further comprises areservoir plug coupled to said wick holder and adapted to cooperate withsaid reservoir in sealing engagement to form a fluid-tight sealtherebetween.
 15. The sampling and testing device of claim 14 whereinsaid reservoir plug includes a sealing ring circumscribing saidreservoir plug.